Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexDivision of the Federal Register, the National Archives, 1998 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
No grāmatas satura
6.–10. rezultāts no 56.
65. lappuse
... sponsor's noncompliance would not pose a significant and unrea- sonable risk to human subjects of the investigation and that one of the fol- lowing is met : ( 1 ) The sponsor's compliance with the requirement is unnecessary for the ...
... sponsor's noncompliance would not pose a significant and unrea- sonable risk to human subjects of the investigation and that one of the fol- lowing is met : ( 1 ) The sponsor's compliance with the requirement is unnecessary for the ...
66. lappuse
... sponsor - inves- tigator who uses , as a research tool , an investigational new drug that is al- ready subject to a manufacturer's IND or marketing application should follow the same general format , but ordi- narily may , if authorized ...
... sponsor - inves- tigator who uses , as a research tool , an investigational new drug that is al- ready subject to a manufacturer's IND or marketing application should follow the same general format , but ordi- narily may , if authorized ...
67. lappuse
... sponsor or the sponsor's authorized representa- tive . If the person signing the applica- tion does not reside or have a place of business within the United States , the IND is required to contain the name and address of , and be ...
... sponsor or the sponsor's authorized representa- tive . If the person signing the applica- tion does not reside or have a place of business within the United States , the IND is required to contain the name and address of , and be ...
68. lappuse
... sponsor should sub- mit information amendments to sup- plement the initial information sub- mitted on the chemistry , manufactur- ing , and control processes with infor- mation appropriate to the expanded scope of the investigation ...
... sponsor should sub- mit information amendments to sup- plement the initial information sub- mitted on the chemistry , manufactur- ing , and control processes with infor- mation appropriate to the expanded scope of the investigation ...
69. lappuse
... sponsor has concluded that it is reasonably safe to conduct the proposed clinical investigations . The kind , duration , and scope of animal and other tests required varies with the du- ration and nature of the proposed clini- cal ...
... sponsor has concluded that it is reasonably safe to conduct the proposed clinical investigations . The kind , duration , and scope of animal and other tests required varies with the du- ration and nature of the proposed clini- cal ...
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abbre abbreviated application abbreviated new drug acid active ingredient adverse drug experience agency amended antibiotic application or abbreviated bacitracin bioavailability bioequivalence cation Center for Drug certification chapter clinical hold clinical investigation conducted control number copy Cosmetic Act digoxin dosage form dose Drug Administration drug application Drug Evaluation drug prod drug product Drug products containing drug substance Evaluation and Research Federal Food Food and Drug graph gredients hearing hydrochloride identified information requirements ap insulin intended inves investigational new drug labeling manufacturer marketing meet ment milligrams milliliters misbranded neomycin notice oral dosage orphan drug OTC drug product package paragraph percent person plication polymyxin proposed protocol recognized as safe reference listed drug request safe and effective safety section 502 Sodium sponsor statement submission Subpart sulfate tained tigational tion tive treatment treatment IND vestigational viated warning